Type 1 Diabetes mellitus
Conditions
Interventions
This is a randomized clinical trial. Patients of both sexes aged 18 years or older and 35 years or older with a confirmed diagnosis of stage 2 preclinical autoimmune diabetes mellitus through the pres
patients with a clinical-laboratory diagnosis of diabetes
patients on insulin therapy or any other hypoglycemic therapy at the time of inclusion
patients with CRF
users of corticosteroids. Patients will be randomized into 2 groups: Group 1- linagliptin 25mg/day and Group 2- no drug intervention. The variables of disease duration, previous use of vitamin D and s
using a power of 80% and a significance level of 5%. Patients will be followed for 24 months from randomization to the group 1 with linagliptin 25mg/day or group 2 without drug intervention for clinic
D27.505.519.389.745.335
Sponsors
Universidade Federal do Ceará
Universidade de São Paulo - Ribeirão Preto
Eligibility
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: Patients of both sexes aged between 18 and 35 years; Confirmed diagnosis of stage 2 autoimmune diabetes mellitus through the presence of 1 or more positive pancreatic islet autoantibodies anti-insulin antibodies, anti-GAD, IA-2, anti-ZnT8A associated with 2 blood glucose values fasting glucose between 100-124 mg/dL or 2 glycated hemoglobin values between 5.7%-6.4% or a fasting glucose between 100-124 mg/dL + 1 glycated hemoglobin value between 5.7%-6.4%
Exclusion criteria
Exclusion criteria: Pregnant women, breast-feeding women or those who wish to conceive in the last 3 months; Patients with a clinical-laboratory diagnosis of diabetes; Patients on insulin therapy or any other hypoglycemic therapy at the time of inclusion; chronic kidney failure carriers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess whether the use of alogliptin 25mg/day in patients with stage 2 type 1 diabetes mellitus reduces the rate of progression to stage 3 at the end of 24 months of follow-up when compared to a control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition to the key outcome, it is expected to compare the following intermediate outcomes between the two groups: A1c, fasting blood glucose and every 30 minutes during 2-hour oral glucose tolerance test; fasting and C-peptide levels at 120 minutes. We will monitor fasting blood glucose, A1c and fasting C-peptide levels every 3 months. Glucose, C-peptide and 25-hydroxyvitamin D levels will be monitored every 6 months. For patients progressing to stage 3, we will assess the dose of exogenous insulin requirement, IDAA1c, and incidence of diabetic ketoacidosis. | — |
Countries
Brazil
Contacts
Public ContactJaquellyne Penaforte-Saboia
Universidade Federal do Ceará
Outcome results
None listed